Bill Sardithe vitamin supplement answer man

The recent failure of an Alzheimer’s drug trial threatens to leave the world with no effective remedies to head off an explosive increase in the numbers of people affected by this disease. By the year 2040 there may be as many as 80 million human zombies on the planet, adults who have lost their memory, ability to communicate, make judgments and live independently.

Recognizing humanity is running out of time, that the lengthening lifespans across the globe will surely increase the incidence of Alzheimer’s dementia, drug companies have stepped up their research and development programs in hopes of reaping huge financial rewards. But sadly their efforts have fizzled.

Two major drug trials were in the research and development pipeline but one was just nixed off the list when the drug (bapineuzumab) was withdrawn from further human study by its pharmaceutical sponsors. That leaves another similar drug (solanezumab) as possibly the last hope for millions of senior adults suffering from this debilitating brain disease. Data will soon be announced on this drug, but this author doesn’t give it much hope, as it is a monoclonal antibody drug in the same class as the failed bapineuzumab.

Still other researchers hold out hope for solanezumab saying it has a good safety profile so far in Phase II studies among Alzheimer’s patients and favorably alters cerebrospinal and blood plasma markers. But altering markers is a long way from heading off this slowly progressive disease.

Have to diagnose it first

Even if a drug is proven to be effective in heading off the progression of the disease, modern medicine first has to agree upon an early pre-disease marker (a blood test most likely) that can be quantified.

Barnabas Wilson, writing from the Department of Pharmaceutics, Dayananda Sagar College of Pharmacy, in Bangalore, India, says:

“The major problem with Alzheimer’s disease is its diagnosis. Even though magnetic resonance imaging, positron emission tomography, single positron emission computerized tomography, spinal fluid biochemistry and other laboratory tests are helpful to identify and study disease progression, a simple and effective diagnostic test is required to identify the disease at an early stage of disease progression. Lack of awareness results in low rates of recognition of disease by family members and physicians… Reportedly, the rates of such failure to recognize cases are 97% for mild Alzheimer’s disease and 50% for moderate Alzheimer’s disease.”

Researchers have recently identified four blood markers (TNF (tumor necrosis factor), apolipoprotein E, C-reactive protein and B-type natriuretic peptide) as possible blood tests that could be employed to identify patients with the earlier signs of the disease.

Modern medicine currently prescribes ineffective drugs

Because of desperate pleas from families of loved ones affected by this brain disease, physicians often pacify their patients and prescribe ineffective drugs. While it is widely reported that “there are no medicines on the market that slow the progression of the disease,” the pharmaceutical industry sells millions of dollars of ineffective drugs for use among Alzheimer’s patients, an enzyme (acetycholinesterase) inhibitor being the most commonly prescribed.

(Let’s see if health reform is going to put a halt to these ineffectual drugs and trigger a public upheaval that will likely end up parading Alzheimer’s patients and their families before Congress in hearings to decide if withholding these drugs represents rationing.)

But wait, there is another drug

John Gever, writing at Med Page Today, says with children of Alzheimer’s disease patients clamoring for a drug, in this case a drug that is already FDA approved but for another condition entirely (cutaneous T-cell lymphoma), puts physicians in an awkward position. The drug is bexarotene. When bexarotene was used among laboratory mice genetically bred to develop amyloid plaque in their brains. It astonishingly reduced the plaques by 50% within 72 hours. While other drugs have been successful in animal models of Alzheimer’s disease, they have failed in human trials, including one of the recent drugs (bapineuzumab) where a human trial was halted.

But while Gregory Jicha MD, PhD, at the University of Kentucky at Lexington, says bexarotene should not be prescribed until tested “with appropriate safety oversight,” he also says “the impetus to do something is quite high.” But the true safety profile of FDA approved drugs is not even known till they are put into use in large groups. Late safety data is what brought the recalls of drugs like Vioxx. And bexarotene is already known to have a host of adverse effects which includes liver damage, pancreatitis, hypothyroidism, leukopenia (low white blood cell count) and elevated cholesterol. This sounds like disease substitution, not disease prevention. But the question arises, will physicians begin to prescribe bexarotene for off label use?

Researchers at the National Institutes of Health (NIH), writing in the New England Journal of Medicine, have dropped the idea that any promising small group study using bexarotene among patients with early Alzheimer’s might prompt families of affected loved ones to beg their doctors for this drug. Sudden overwhelming pleas to do something by family members may be difficult for politicians to deal with and they might exert pressure to prescribe. The NIH researchers say “the early promise of bexarotene in a mouse model of Alzheimer’s disease is exciting.”

But why have NIH researchers chosen bexarotene over many other promising molecules, most of them being dietary supplements? Why not off-label use of dietary supplements for Alzheimer’s disease. The pro-drug lobby can’t say these natural remedies are unproven because neither are the drugs. In fact, some have been disproven but millions of dollars of these ineffective pills are still prescribed. There is at least as much scientific evidence for dietary supplements as remedies for Alzheimer’s disease as there is for bexarotene, so why aren’t NIH researchers “excited” about them?

Special precaution

Researchers have already employed fairly high-dose antioxidants (vitamin E, vitamin C, lipoic acid, coenzyme Q10) among subjects with mild to moderate Alzheimer’s disease, but these appeared to accelerate mental decline over a period of 16 weeks even though a marker of oxidation declined in cerebrospinal fluid. Markers of tau protein and beta amyloid did not decline with use of this antioxidant cocktail. The relative high dosage of antioxidant used in this study may be the problem here.

What modern medicine should be studying are the cases of minimal brain plaque that have been confirmed among a few centenarians. It is possible to live 100+ years and not be senile. Documentation is found here and here. What is striking is that neither the number of surviving brain cells (neurons) nor volume of amyloid brain plaque is significantly related to the clinical dementia rating that geriatricians use to measure severity of Alzheimer’s disease in these centenarians.

Many small natural molecules from botanical sources are naturally nano-sized and do not require nano-sizing by man. Included in a list of naturally nano-sized molecules that may have application for Alzheimer’s disease are the following: